A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

Last updated: March 27, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

2

Condition

Psoriatic Arthritis

Joint Injuries

Treatment

Golimumab

Guselkumab

Placebo

Clinical Study ID

NCT05071664
CR109054
CNTO1959PSA2003
2021-002012-31
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy of guselkumab plus golimumab combination treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) to prior anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapies by assessing clinical response compared with guselkumab monotherapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of psoriatic arthritis (PsA) for greater than or equal to (>=) 6months prior to the first administration of study intervention and meetClassification criteria for PsA (CASPAR) criteria at screening

  • Have active PsA as defined by having at least 3 swollen joints and at least 3 tenderjoints at screening and at baseline

  • Have at least 1 of the following PsA subsets: distal interphalangeal jointinvolvement, polyarticular arthritis with absence of rheumatoid nodules, arthritismutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis

  • Have active plaque psoriasis, with at least one psoriatic plaque of >=2 centimeter (cm) diameter or nail changes consistent with psoriasis

  • Have an inadequate response (IR) to anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapy, defined as presence of active PsA despite treatment witheither 1 or 2 prior anti-TNF-alpha agent(s) and the following: a. Lack of benefit toeither 1 or 2 prior anti-TNF-alpha therapies, as documented in the participanthistory by the treating physician, after at least 12 weeks of etanercept,adalimumab, or certolizumab pegol therapy, or at least 14-weeks of infliximab, orany biosimilar of these 4 therapies. Documented lack of benefit may includeinadequate improvement in joint counts, physical function, or disease activity; b.The last dose of anti-TNF-alpha therapy must have occurred greater than 5 half-livesof the drug prior to first study intervention administration (washout period)

Exclusion

Exclusion Criteria:

  • Has other inflammatory diseases that might confound the evaluations of benefit ofguselkumab and/or golimumab therapy, including but not limited to rheumatoidarthritis (RA), ankylosing spondylitis (AS), nonradiographic axial spondyloarthritis (nr AxSpA), systemic lupus erythematosus, or lyme disease

  • Has known intolerance or hypersensitivity to any biologic medication, or knownallergies or clinically significant reactions to murine, chimeric, or humanproteins, monoclonal antibodies (mAb), or antibody fragments

  • Has received prior treatment with golimumab or guselkumab or has documentedintolerance to prior anti-TNF-alpha therapy in the participant history by thetreating physician

  • Has received more than 2 prior anti-TNF-alpha agents (or biosimilars)

  • Positive human immunodeficiency virus (HIV) antibody test

Study Design

Total Participants: 91
Treatment Group(s): 3
Primary Treatment: Golimumab
Phase: 2
Study Start date:
October 25, 2021
Estimated Completion Date:
August 06, 2024

Study Description

PsA is a chronic inflammatory multi-faceted disease that impacts the peripheral and axial joints, soft tissues, and skin. Guselkumab is a fully human monoclonal antibody (mAb) directed against the p19 subunit of interleukin (IL)-23, blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling, subsequent activation, and cytokine production. Golimumab is a fully human anti-TNF-alpha mAb that binds to TNF-alpha with high affinity, prevents binding to its receptors, thereby inhibiting the biological activity of TNF-alpha and resulting in limited production or activity of inflammatory cytokines, thereby providing therapeutic benefit in various chronic inflammatory disorders, including PsA. This study will consist of a Screening Phase (up to 6 weeks), Double-blind Phase from Weeks 0 to 24 which includes the active treatment phase and the primary efficacy visit (Week 24), and Safety Follow-up Phase from Week 24 to Week 36. Key safety assessments will include adverse events (AEs), clinical laboratory safety tests (hematology and chemistry), vital signs, monitoring for injection-site and hypersensitivity reactions, and early detection of active tuberculosis (TB). The total duration of the study is up to 42 weeks.

Connect with a study center

  • Frederiksberg Hospital

    Frederiksberg, 2000
    Denmark

    Site Not Available

  • Rigshospitalet Glostrup

    Glostrup, 2600
    Denmark

    Site Not Available

  • Køge Sygehus Region Sjaelland

    Køge, 4600
    Denmark

    Site Not Available

  • Silkeborg Hospital

    Silkeborg, 8600
    Denmark

    Site Not Available

  • Vejle Sygehus

    Vejle, 7100
    Denmark

    Site Not Available

  • Centre Hospitalier Le Mans

    Le Mans, 72037
    France

    Site Not Available

  • Hospital Center Regional D'orleans Hospital La Source

    Orleans cedex 2, 45067
    France

    Site Not Available

  • Hopital Larrey CHU de Toulouse

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • CHU Trousseau - Service de Rhumatologie

    Tours, 37044
    France

    Site Not Available

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036
    Hungary

    Site Not Available

  • Obudai Egeszsegugyi Centrum Kft.

    Budapest, 1036
    Hungary

    Site Not Available

  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

    Gyula, 5700
    Hungary

    Site Not Available

  • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

    Gyula, 5700
    Hungary

    Site Not Available

  • Complex Rendelo Med Zrt

    Szekesfehervar, 8000
    Hungary

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  • Complex Rendelo Med Zrt

    Székesfehérvár, 8000
    Hungary

    Site Not Available

  • Vital Medical Center

    Veszprem, 8200
    Hungary

    Site Not Available

  • Vital Medical Center Orvosi es Fogaszati Kozpont

    Veszprem, 8200
    Hungary

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Cagliari

    Cagliari, 09124
    Italy

    Site Not Available

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO

    Milano, 20122
    Italy

    Site Not Available

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

    Milano, 20122
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli

    Napoli, 80138
    Italy

    Site Not Available

  • IRCCS Policlinico San Matteo, Università degli studi di Pavi

    Pavia, 27100
    Italy

    Site Not Available

  • Arcispedale Santa Maria Nuova - IRCCS

    Reggio Emilia, 42123
    Italy

    Site Not Available

  • A.O.U.Policlinico Tor Vergata

    Roma, 00133
    Italy

    Site Not Available

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • Università Campus Biomedico di Roma

    Rome, 00128
    Italy

    Site Not Available

  • AO Ordine Mauriziano

    Torino, 10128
    Italy

    Site Not Available

  • Ospedale Mauriziano (Torino)

    Torino, 10128
    Italy

    Site Not Available

  • Centrum Kliniczno Badawcze

    Elblag, 82 300
    Poland

    Site Not Available

  • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

    Lodz, 90-242
    Poland

    Site Not Available

  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

    Lodz, 90-242
    Poland

    Site Not Available

  • NZOZ Lecznica MAK MED S C

    Nadarzyn, 05 830
    Poland

    Site Not Available

  • NZOZ Lecznica MAK-MED. S.C.

    Nadarzyn, 05-830
    Poland

    Site Not Available

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sol, 67-100
    Poland

    Site Not Available

  • Centrum Medyczne

    Poznan, 61 113
    Poland

    Site Not Available

  • Medycyna Kliniczna

    Warsaw, 00-874
    Poland

    Site Not Available

  • Centrum Medyczne AMED Targowek

    Warszawa, 03 291
    Poland

    Site Not Available

  • Centrum Medyczne AMED Warszawa Targowek

    Warszawa, 03-291
    Poland

    Completed

  • Centrum Medyczne FutureMeds Targowek

    Warszawa, 03-291
    Poland

    Completed

  • WroMedica I Bielicka A Strzalkowska s c

    Wroclaw, 51 685
    Poland

    Site Not Available

  • WroMedica I.Bielicka, A.Strzalkowska s.c.

    Wrocław, 51-685
    Poland

    Site Not Available

  • WroMedica I.Bielicka, A.Strzałkowska s.c.

    Wrocław, 51-685
    Poland

    Site Not Available

  • Chelyabinck Regional Clinical Hospital

    Chelyabinsk, 454076
    Russian Federation

    Site Not Available

  • Kemerovo State Medical University

    Kemerovo, 650000
    Russian Federation

    Site Not Available

  • LLL Medical Center Revma-Med

    Kemerovo, 650070
    Russian Federation

    Site Not Available

  • LLC Family Outpatient Clinic # 4

    Korolev, 141060
    Russian Federation

    Site Not Available

  • Krasnodar Clinical Dermatovenerologic Dispensary

    Krasnodar, 350020
    Russian Federation

    Site Not Available

  • GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'

    Moscow, 129110
    Russian Federation

    Site Not Available

  • Orenburg State Medical Academy

    Orenburg, 460000
    Russian Federation

    Site Not Available

  • Rostov Regional Clinical Dermatovenerological Dispensary

    Rostov, 344007
    Russian Federation

    Site Not Available

  • Ryazan Regional Clinical Dermatovenerological Dispensary

    Ryazan, 390046
    Russian Federation

    Site Not Available

  • Smolensk regional hospital on Smolensk railway station

    Smolensk, 214025
    Russian Federation

    Site Not Available

  • Medical Center Uninova Llc

    St-Petersburg, 194156
    Russian Federation

    Site Not Available

  • X7 Clinical Research Company Limited

    St. Petersburg, 194156
    Russian Federation

    Site Not Available

  • Tula Regional Clinical Dermatovenerological Dispensary

    Tula, 300053
    Russian Federation

    Site Not Available

  • Republican Clinical Hospital - G.G. Kuvatov

    Ufa, 450005
    Russian Federation

    Site Not Available

  • Clinical Hospital #3

    Yaroslavl, 150007
    Russian Federation

    Site Not Available

  • Hosp Univ A Coruna

    A Coruna, 15006
    Spain

    Site Not Available

  • Hosp. Univ. A Coruna

    A Coruna, 15006
    Spain

    Site Not Available

  • Hosp. Univ. A Coruna

    A Coruña, 15006
    Spain

    Site Not Available

  • Hosp. Univ. A Coruña

    A Coruña, 15006
    Spain

    Active - Recruiting

  • Hosp. Univ. Germans Trias I Pujol

    Barcelona, 08916
    Spain

    Site Not Available

  • Hosp. Univ. de Basurto

    Bilbao, 48013
    Spain

    Site Not Available

  • Hosp Reina Sofia

    Cordoba, 14004
    Spain

    Site Not Available

  • Hosp. Reina Sofia

    Cordoba, 14004
    Spain

    Site Not Available

  • Hosp. Reina Sofia

    Córdoba, 14004
    Spain

    Site Not Available

  • Hosp. Univ. 12 De Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Hosp. Infanta Luisa

    Sevilla, 41010
    Spain

    Site Not Available

  • Hosp. Ntra. Sra. de Valme

    Sevilla, 41014
    Spain

    Site Not Available

  • Hosp. Virgen Macarena

    Sevilla, 41009
    Spain

    Site Not Available

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Linkoping University Hospital

    Linkoping, 581 85
    Sweden

    Site Not Available

  • Skanes universitetssjukhus

    Malmo, 205 02
    Sweden

    Site Not Available

  • Karolinska Universitetssjukhuset Solna

    Solna, 171 76
    Sweden

    Site Not Available

  • Akademiskt Specialistcentrum centrum för reumatologi

    Stockholm, 113 65
    Sweden

    Site Not Available

  • Municipal Institution Regional hospital-center of emergency care and disasters medicine

    Kharkiv, 61204
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    Site Not Available

  • State Institution Institute of therapy named after L.T.Malaya AMS Ukraine

    Kharkiv, 61039
    Ukraine

    Site Not Available

  • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

    Kyiv, 03049
    Ukraine

    Site Not Available

  • Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud

    Kyiv, 03037
    Ukraine

    Site Not Available

  • Municipal Non-Profit Enterprise of Kyiv Regional Council 'Kyiv regional Clinical Hospital'

    Kyiv, 04107
    Ukraine

    Site Not Available

  • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

    Kyiv, 03680
    Ukraine

    Site Not Available

  • ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil

    Poltava, 36011
    Ukraine

    Site Not Available

  • Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

    Ternopil, 46002
    Ukraine

    Site Not Available

  • MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council

    Uzhgorod, 88000
    Ukraine

    Site Not Available

  • Health Clinic Limited Liability Company

    Vinnytsia, 21009
    Ukraine

    Site Not Available

  • Medical Center LLC 'Modern Clinic'

    Zaporizhzhya, 69600
    Ukraine

    Site Not Available

  • Arizona Arthritis and Rheumatology Research PLLC

    Phoenix, Arizona 85037
    United States

    Site Not Available

  • Arizona Arthritis and Rheumatology Research, PLLC

    Phoenix, Arizona 85037
    United States

    Site Not Available

  • Unity Health-White County Medical Center

    Searcy, Arkansas 72143
    United States

    Site Not Available

  • HARAC Research Corp

    Avon Park, Florida 33825
    United States

    Site Not Available

  • Bay Pines VA Healthcare System

    Bay Pines, Florida 33744
    United States

    Site Not Available

  • Omega Research Consultants

    DeBary, Florida 32713
    United States

    Site Not Available

  • Sweet Hope Research Specialty, Inc.

    Hialeah, Florida 33016
    United States

    Site Not Available

  • South Coast Research Center

    Miami, Florida 33136
    United States

    Site Not Available

  • Advanced Clinical Research of Orlando

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Millennium Research

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Atlanta Research Center for Rheumatology

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Great Lakes Center of Rheumatology

    Lansing, Michigan 48911
    United States

    Site Not Available

  • Clinvest

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Excel Clinical Research

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Jacobi Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • NYC Health & Hospitals

    Bronx, New York 10451
    United States

    Site Not Available

  • NYU Langone Ambulatory Care Brooklyn Heights

    Brooklyn, New York 11201
    United States

    Site Not Available

  • NYU School of Medicine

    New York, New York 10016
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • STAT Research, Inc.

    Vandalia, Ohio 45377
    United States

    Site Not Available

  • VA North Texas Health Care System

    Dallas, Texas 75216
    United States

    Site Not Available

  • West Texas Clinical Research

    Lubbock, Texas 79410
    United States

    Site Not Available

  • Trinity Universal Research Associates, LLC

    Plano, Texas 75024
    United States

    Site Not Available

  • Epic Medical Research

    Red Oak, Texas 75154
    United States

    Site Not Available

  • Advanced Rheumatology of Houston

    The Woodlands, Texas 77382
    United States

    Site Not Available

  • DM Clinical Research

    Tomball, Texas 77375
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Site Not Available

  • Center of Rheumatic Diseases

    Glendale, Wisconsin 53217
    United States

    Site Not Available

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